Prospective Evaluation of Combined Laparoscopy With CO2 Intraoperative Colonoscopy Treatment for Colorectal Lesions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00725465
First received: July 24, 2008
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to evaluate prospectively the usefulness of IC-CO2(intraoperative colonoscopy (IC) using carbon dioxide (CO2)) in our colon and rectal surgical practice, coincident with laparoscopic surgery, and assess whether it provides useful information that influences the type of surgical therapy intended. We also wish to further define the safety and extent of bowel distension when using IC-CO2. Furthermore, we wish to evaluate the therapy and technique of using this combined approach to the treatment of colorectal polyps and other localized, benign lesions of the large intestine. In this study, the colonoscope is used both as a diagnostic and therapeutic tool, and is often used in order to avoid a major bowel resection, yet effectively treat localized lesions of the large intestine.

The hypothesis of this study is that IC-CO2 will provide useful information which does affect surgical decision making at the time of operation, and that it is safe and does not result in any significant bowel distention during or immediately after the procedure. We additionally hypothesize that certain localized lesions of the intestines may be treated using a combined laparoscopic-IC-CO2 approach to effectively treat the underlying disease, minimize risks to the patient, and avoid a major bowel resection.


Condition
Colorectal Polyps

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Combined Laparoscopy With CO2 Intraoperative Colonoscopy Treatment for Colorectal Lesions

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • arterial blood gas (ABG) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 2006
Groups/Cohorts
30
30 surgical patients, male and female undergoing laparoscopic surgical treatment for colorectal conditions managed with intra-operative CO2 colonoscopy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

30 surgical patients, male and female undergoing laparoscopic surgical treatment for colorectal conditions managed with intra-operative colonoscopy for standard care of their medical condition

Criteria

Inclusion Criteria:

  • All patients (male and female) greater than 18 years of age who undergo a laparoscopic surgical procedure that utilizes intra-operative colonoscopy will be approached to participate in this study

Exclusion Criteria:

  • Patients under 18 year of age
  • Patients with severe Renal Diseases
  • Ascites
  • COPD (severe)
  • Liver insufficiency (severe) with coagulopathy
  • Dialysis
  • Sleep Apnea
  • Patient pregnant
  • Multiple previous surgeries
  • Subject is incapable of understanding the informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725465

Contacts
Contact: Jeffrey w Milsom, MD 212-746 5278 jwm2001@med.cornell.edu
Contact: Koiana Trencheva, BSN 212-746 5241 kivanova@med.cornell.edu

Locations
United States, New York
Weill Medical College Recruiting
New York, New York, United States, 10065
Contact: Jeffrey W Milsom, MD    212-746-5278    jwm2001@med.cornell.edu   
Contact: Koiana Trencheva, BSN    212-746 5241    kivanova@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Jeffrey Milsom,MD, Weill Medical College
ClinicalTrials.gov Identifier: NCT00725465     History of Changes
Other Study ID Numbers: 0411007608
Study First Received: July 24, 2008
Last Updated: March 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
laparoscopy
CO2 colonoscopy
intraoperative CO2 colonoscopy
combined Lap-CO2 procedure
to evaluate simultaneous CO2 laparoscopy and colonoscopy safety and physiologic effects on patients from the additional CO2 insufflation

ClinicalTrials.gov processed this record on July 31, 2014